Intra-Articular Catheter for Total Knee Replacement

Overseen By Caleb J Michalek, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: OrthoCarolina Research Institute, Inc.

Must not be taking: Opiate pain medications

Disqualifiers: Chronic pain, Neuropathic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

65 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken opiate pain medication within 6 weeks before surgery.

What data supports the effectiveness of the intra-articular catheter treatment for total knee replacement?

Research shows that intra-articular catheters can effectively reduce pain after knee replacement surgery by delivering pain relief directly to the surgical area. However, there are concerns about a potential increase in infection rates with their use. ^{1 2 3 4 5}

Is the intra-articular catheter safe for use in total knee replacement?

There are concerns that using intra-articular pain catheters in total knee replacement might increase the risk of deep infections, although they help reduce pain after surgery. ^{1 2 6 7 8}

How does the intra-articular catheter treatment differ from other treatments for total knee replacement?

The intra-articular catheter treatment is unique because it delivers pain relief directly to the surgical site inside the knee joint, which can be more effective in controlling pain compared to other methods like epidural catheters. However, there are concerns about a potential increase in deep infections with this method. ^{1 2 7 8 9}

What is the purpose of this trial?

This is a prospective, randomized clinical trial evaluating three groups. The groups are: Group 1 (Control): Subjects that receive only the existing standard-of-care multimodal pain management protocol and do not receive post-operative intra-articular catheter. Group 2 (Investigational Treatment/Intervention): Subjects that receive the brand 1 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period. Group 3 (Investigational Treatment/Intervention): Subjects that receive the newer brand 2 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period.

Eligibility Criteria

This trial is for individuals undergoing total knee replacement who can follow the post-operative pain management protocol. Specific eligibility details are not provided, but typically participants must meet certain health criteria and not have conditions that would exclude them from safely participating.

Inclusion Criteria

I am scheduled for a knee replacement surgery at Mallard Creek Surgery Center.

Subjects who are indicated to use an intra-articular catheter pump system

Subjects willing and able to provide written informed consent to participate in this study

Exclusion Criteria

I am under 18 years old.

Subjects with history of chronic pain, neuropathic pain, or currently enrolled in pain management agreement

I have taken opiate pain medication within 6 weeks before my surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative

Participants undergo total knee arthroplasty and receive either standard care or an intra-articular catheter for pain management

Immediate post-operative period

1 visit (in-person)

Treatment

Participants receive pain management with or without intra-articular catheter and are monitored for pain scores

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and knee function

6 weeks

2 visits (in-person)

Treatment Details

Interventions

• Intra-articular catheter

Trial Overview The study compares three approaches to manage pain after knee surgery: standard care alone (Group 1), standard care plus a brand 1 intra-articular catheter pump (Group 2), and standard care with a newer brand 2 catheter pump (Group 3). Patients are randomly assigned to one of these groups.

Participant Groups

Group I: No post-operative intra-articular catheter Experimental Treatment 1 Intervention

Subjects that receive ONLY the existing standard of care (SOC) multimodal pain management protocol and DO NOT receive post-operative intra-articular catheter.

Group II: BRAND 1 intra-articular catheter Active Control 1 Intervention

Subjects that receive the BRAND 1 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period.

Group III: BRAND 2 intra-articular catheter Active Control 1 Intervention

Subjects that receive the newer BRAND 2 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Infection rates with use of intra-articular pain catheters in total knee arthroplasty. [2017]

2. Spain pubmed.ncbi.nlm.nih.gov

The use of an intraarticular catheter on fast-track primary knee arthroplasty, is it a step forward? [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Comparing the efficacy of intra-articular application of morphine and tramadol on postoperative pain after arthroscopic knee surgery. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia after total knee arthroplasty: Continuous intra-articular catheter vs. continuous femoral nerve block]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Epidural versus intra-articular infusion analgesia following total knee replacement. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Tourniquet use in total knee arthroplasty: a meta-analysis. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Influence of wound drainage in primary total knee arthroplasty without tourniquet. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Risk factors for postoperative indwelling catheter following enhanced recovery after total knee arthroplasty]. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Local infusion analgesia using intra-articular double lumen catheter after total knee arthroplasty: a double blinded randomized control study. [2021]